Reference Source

Cosmo Sonic Inc · 89-08 · JAPAN

For Cosmo Sonic Inc, import alert is 89-08; country is JAPAN; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Devices; product code is 89 - - - -- Physical Medicine; date published is 05/14/2014; address is 1-17 4 Hongo , Bunkyo-Ku, Tokyo JAPAN, verified against its source on 2026-09-30.

Firm
Cosmo Sonic Inc verified
Import alert
89-08
Import alert name
"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
Country
JAPAN verified
Address
1-17 4 Hongo , Bunkyo-Ku, Tokyo JAPAN verified
Date published
05/14/2014 verified
Product code
89 - - - -- Physical Medicine verified
Product
Devices verified
FDA notes
Class II verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Cosmo Sonic Inc Date Published : 05/14/2014 1-17 4 Hongo , Bunkyo-Ku, Tokyo JAPAN

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

89 - - - -- Physical Medicine Date Published: 05/14/2014 Desc: Devices Notes: Class II

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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